GALT MEDICAL GUIDEWIRE


Device Classification Name

wire, guide, catheter

510(k) Number K021990
Device Name GALT MEDICAL GUIDEWIRE
Original Applicant
GALT MEDICAL CORP.
2475 merritt dr.
garland, 
TX 
75041

Original Contact david catlin
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 06/18/2002
Decision Date 07/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No